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Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study

NCT00768742 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-11-25

No results posted yet for this study

Summary

The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.

Conditions

  • Leiomyoma
  • Uterine Fibroids
  • Menorrhagia

Interventions

DEVICE

VizAblate Intrauterine Ultrasound-Guided RF Ablation

VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.

Sponsors & Collaborators

  • Gynesonics

    lead INDUSTRY

Principal Investigators

  • David Toub, M.D. · Gynesonics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00768742 on ClinicalTrials.gov